Surgical instrument seal assembly

ABSTRACT

A surgical instrument valve assembly is provided with a valve seal where the upper portion of the valve seal is rigidly mounted to the body of the valve assembly. The lower portion of the valve seal is configured to allow some radial movement while the upper portion of the valve seal remains rigidly mounted within the valve assembly. The valve seal may be provided with a stay that prevents the valve seal from inverting when an instrument in withdrawn from the valve assembly.

[0001] This application is a continuation of U.S. application Ser. No.09/885,856, filed Jun. 20, 2001, which is a continuation of U.S.application Ser. No. 09/434,608 filed Nov. 5, 1999, now U.S. Pat. No.6,258,065, which claims the benefit of Provisional Application No.60/126,356 filed on Mar. 26, 1999, all of which are incorporated hereinby reference in their entirety. This application is also related to U.S.application Ser. No. 09/950,274, filed Sep. 12, 2001.

FIELD OF THE INVENTION

[0002] The present invention relates broadly to medical devices usedduring surgical procedures and, more particularly to a surgicalinstrument seal assembly for selective mounting to a cannula for theinsertion of a surgical instrument therethrough while maintaining afluid seal around the instrument.

BACKGROUND OF THE INVENTION

[0003] In certain types of surgery, a cannula is used to provide apassageway into a body cavity through which surgical instruments may bepassed. Cannulas are typically elongate rod-like members having a boretherethrough the surgical instrument may be passed through the bore. Attimes, the body cavity will be insufflated by a gas and at all times,the cannula will be subjected to internal body fluids. Therefore, someform of seal assembly is necessary to allow the surgical instrument topass while maintaining sealed integrity around the instrument such thatthe insufflation gas, the internal body fluids, or both, cannot escape.

[0004] Typically, in conventional devices, such a seal mechanism willinclude a housing for mounting on the cannula, with the housing having abore therethrough for passage of the surgical instrument. Two seals aretypically located within the housing. The lower housing contains a seal,typically called a duckbill valve that assists maintaining gases andfluids in place when an instrument is not inserted within the duckbillvalve. The duckbill valve is typically formed from flexible material andincludes a slit opening that gives way to the instrument upon insertion.The upper housing typically includes a valve seal that includes arelative wide access opening and a relatively narrow valve opening. Thevalve opening can expand to accommodate the surgical instrument and issufficiently resilient to form a seal around the instrument uponinsertion.

SUMMARY OF THE INVENTION

[0005] However, certain problems have been identified in conjunctionwith use and operation of conventional devices. Initially, theelastomeric material of the valve seal can be damaged by contact withthe surgical instrument upon insertion. As a result, seal protectorshave been used. The seal protectors are units separate from the valveseal and disposed intermediate the seal and a surgical instrument. Someseal protectors include complex lever arrangements that may engage andopen the valve opening while acting as a barrier between the instrumentand the valve seal. Other approaches include the application of rigidplastic leaf-like members in an overlapping, circular array in abutmentwith the valve seal. The overlapping arrangement allows the leaves toopen upon insertion of an instrument. These approaches have beengenerally costly and complex.

[0006] Another problem with conventional devices has been the inabilityof the valve opening to align with the instrument if the instrument isinserted “off axis,” i.e., out of alignment with the throughbore in thevalve seal. Attempts to resolve this problem have resulted in specialmounting arrangements for the valve seal wherein the valve seal islaterally displaceable within a housing holding the valve seal. Thesesolutions have required additional material and can be expensive andcomplex.

[0007] Therefore, there is a need for a surgical instrument sealingassembly that provides protection for the valve seal during contact withthe instrument, especially during off axis insertion of the instrument,that is inexpensive and simple to produce.

[0008] It is accordingly an object of the present invention to provide asurgical instrument seal assembly having a valve seal that can withstandimpact from a surgical instrument.

[0009] As another object of the present invention a seal assembly isprovided that protects the valve seal upon off axis insertion of asurgical instrument.

[0010] It is another object of the present invention to provide a sealassembly that is simple and easy to produce.

[0011] Accordingly, a surgical instrument seal assembly is provided asdescribed in the description of the exemplary embodiments. The presentinvention provides a unitary valve seal that includes an armorreinforcement that is unitarily formed with the elastomeric sealmaterial and protects the integrity of the elastomeric seal materialduring insertion of the surgical instrument. Further, the valve seal isconfigured to allow some off-axis movement of a valve opening in thevalve seal while a mounting portion of the valve seal itself remainsrigidly mounted within its housing. Thus, while the upper portion of thevalve seal may be incapable of lateral movement, the valve openingitself can shift a small amount to accommodate an off-axis instrumentinsertion.

[0012] The surgical instrument seal assembly for mounting to a cannulafor the insertion of a surgical instrument therethrough whilemaintaining a fluid seal around the instrument is provided with an upperbody portion having an upper surface that defines a throughboreextending completely through the seal assembly. A lower body portionprojects below the upper body portion and the lower body portion definesa cannula receiving opening adapted to mount the valve seal assembly onthe cannula. The valve assembly is provided with a unitary valve sealthat has an upper seal portion having a mounting portion rigidly mountedin the upper body portion adjacent the interior portion of the uppersurface wherein the upper seal portion is mounted about the throughboreand a lower seal portion extending from the upper seal portion adaptedto seal around the instrument.

[0013] Further, in accordance with an aspect of the invention, thesurgical instrument seal assembly is provided with a stay wherein atleast a portion of the stay is encapsulated in the valve seal. The staymay be unitarily formed with the lower seal portion.

[0014] The surgical instrument seal assembly, in accordance with anaspect of the invention, is further provided with an upper seal portionand a lower seal portion integrally formed from the same material andwherein the valve seal further comprises a stay partially encapsulatedin the lower seal portion.

[0015] Still further, in accordance with an aspect of the invention, thesurgical instrument seal assembly is provided with a valve seal formedfrom an elastomeric material.

[0016] The surgical instrument seal assembly, in accordance with anaspect of the invention. may be provided with a duckbill valve in thelower body portion.

[0017] In one embodiment, the surgical instrument seal assembly isprovided with a stay that is adapted to resist inversion of the valveseal when an instrument is withdrawn from the valve seal.

[0018] The surgical instrument seal assembly, in accordance with anaspect of the invention, may be provided with a stay made from amaterial selected from the group consisting of polyethylene,polypropylene, nylon, and plastic elastomers. The stay of the surgicalinstrument valve assembly may be shaped to substantially match the lowerseal portion.

[0019] In accordance with an aspect of the invention, the surgicalinstrument seal assembly is provided with a stay wherein at least aportion of the stay is encapsulated in at least a portion of the lowerseal portion.

[0020] Still further, in accordance with an aspect of the invention, thesurgical instrument seal assembly may be provided with a stay having acircumferential flange above at least a portion of the stay encapsulatedin the lower seal portion.

[0021] The surgical instrument seal assembly, in accordance with anaspect of the invention, is provided with a stay wherein at least aportion of the stay is approximately frusto-conical in shape.

[0022] The surgical instrument seal assembly, in accordance with anaspect of the invention, may be provided with a stay where the stay hasa plurality of flexible members.

[0023] Still further, in accordance with the aspect of the invention,the surgical instrument seal assembly may be provided with a staywherein the stay has a lower portion encapsulated by the valve sealmaterial and forms a unitary structure.

[0024] In accordance with an aspect of the present invention, a valveseal for use in a surgical instrument scale assembly is provided with anupper seal portion, a lower seal portion extending from the upper sealportion, and a stay wherein at least a portion of the stay isencapsulated in the lower portion of the valve seal.

[0025] In accordance with an aspect of the present invention, the valveseal may be provided with a stay that is unitarily formed with the lowerseal portion. Further, the upper seal portion and the lower seal portionmay be integrally formed from the same material. Further, the valve sealmay be formed from elastomeric material. The elastomeric material may beselected from the group consisting of silicone, plastic elastomers,polyisoprene, butyl rubber, neoprene, and natural rubber.

[0026] Still further in accordance with an aspect of the presentinvention, the stay may be adapted to resist inversion of the valve sealwhen an instrument is withdrawn from the valve seal. Further, the staymay be made from materials select from the group consisting ofpolyethylene, polypropylene, nylon, and plastic elastomers. Stillfurther, the stay may be shaped to substantially match the shape of thelower seal portion.

[0027] In accordance with another aspect of the present invention, thestay may further comprise circumferential flange above the at least aportion of the stay encapsulated in the lower seal portion. Further, thestay may include a circumferential upper wall disposed above thecircumferential flange. Still further, at least a portion of the staymay be approximately frusto-conical in shape. The stay may be providedwith a plurality of flexible members. In accordance with another aspectof the present invention, the stay may have a lower portion that isencapsulated by the valve seal material and forms a unitary structure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] These and other aspects of the invention will become apparentfrom the following descriptions which illustrate exemplary embodimentsof the invention when read in conjunction with the accompanyingdrawings, in which:

[0029]FIG. 1 is a perspective view of a surgical instrument with a sealassembly according to an exemplary embodiment of the present invention;

[0030]FIG. 2 is a top plan view of the seal assembly illustrated in FIG.1 in accordance with an exemplary embodiment of the present invention;

[0031]FIG. 3 is a cross-sectional view of the seal assembly illustratedin FIG. 1 taken along lines I-I in accordance with an exemplaryembodiment of the present invention;

[0032]FIG. 4 is a bottom view of the seal assembly shown in FIG. 3 inaccordance with an exemplary embodiment of the present invention.

[0033]FIG. 5 is a cross-sectional view of another embodiment of the sealassembly illustrated in FIG. 1 taken along lines I-I in accordance withan exemplary embodiment of the present invention;

[0034]FIG. 6 is a cross-sectional view of the valve seal shown in FIG. 5in accordance with an exemplary embodiment of the present invention;

[0035]FIG. 7 is a side view of the stay used in the valve seal inaccordance with an exemplary embodiment of the present invention; and

[0036]FIG. 8 is a top plan view of the stay shown in FIG. 7 inaccordance with an exemplary embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] With reference to the drawings, wherein like numerals have beenused to represent like features, and, more particularly to FIG. 1, asurgical instrument valve seal assembly 10 is illustrated and includesan upper body portion 12 and a lower body portion 18. The upper bodyportion 12 is generally cylindrical and includes a washer-shaped uppersurface 16 integrally formed with a generally cylindrical sidewall 14. Athroughbore 20 is provided at the center of the upper surface 16 withthe throughbore 20 extending completely through the seal assembly 10. Agenerally cylindrical protector wall member 24 is integrally formed withupper surface 16 at the throughbore 20 to project inwardly into theinterior of the upper body portion 12 to both strengthen the structureand to guide the surgical instrument into the throughbore 20.

[0038] The lower body portion 18 includes a generally cylindrical wall19 projecting below the upper body portion 12. A tapered transition wall21 is disposed intermediate the cylindrical lower wall 19 and the upperbody portion 12, and acts to taper the diameter of the seal assembly 10from the larger upper body portion 12 to the smaller lower body portion18. A cannula receiving opening 22 is formed in the lower body portion18 for mounting the device on a cannula (not shown). It should berecognized that the upper body portion 12, the transition wall 21, andthe lower body portion 18 may be formed from molded polymeric materialfor ease of manufacture.

[0039] With reference to FIG. 2, it can be seen that the throughbore 20provides access to the valve seal 30 and a duckbill valve 42, both ofwhich will be explained in greater detail hereinafter.

[0040] Turning now to FIG. 3, a cross-sectional view of the sealassembly 10 illustrated in FIG. 1 reveals the structure of the sealassembly 10, in accordance with an exemplary embodiment of the presentinvention. It can be seen that the upper body portion 12 is mounted tothe lower body portion 18 with a shoulder 25 formed on the transitionwall 21. The shoulder 25 engages a similar shoulder formed on thecylindrical wall 14 of the upper body portion 12. The two piececonstruction provides for ease of assembly during manufacture.

[0041] Inner support member 28 projects downwardly from an interiorportion 37 of the upper body portion 12, opposite to the upper surface16, into engagement with a shoulder 29 formed on the lower body portion18. The inner support member 28 provides stability for the seal assemblyand a mounting location for a valve seal 30. Preferably, an o-ring 27 islocated between the inner support member 28 and shoulder 29 to form asubstantially leak-tight seal between the upper body portion 12 and thelower body portion 18.

[0042] As shown in FIG. 4 with continuing reference to FIG. 3, the lowerbody portion 18 is configured for mating engagement with a cannula and,accordingly, includes mating members 26 formed adjacent the cannulaopening 22 in the lower body portion 18. For example, the mating members26 may be a plurality of ribs.

[0043] A duckbill valve 42 is formed as an elastomeric member disposedin the lower body portion 18 using a mounting assembly 44. The duckbillvalve 42 includes a slit-like opening 43 that forms a seal, and allowsfor an instrument to be inserted through the cannula. Further, theduckbill valve 42 acts as an initial barrier to gases and fluids.

[0044] Turning now the valve seal 30, a mounting portion 41 of valveseal 30 is rigidly mounted in the upper body portion 12 at a mountingmember 36 on the inner support member 28. That is, the valve seal 30 ismounted adjacent the interior portion 37 opposite to the upper surface16. The valve seal 30, including the mounting member 36 and the innersupport member 28, is rigidly mounted within the upper body portion 12and incapable of lateral shifting, within the upper body portion 12,with respect to either the mounting member 36 or the inner supportmember 28.

[0045] The valve seal 30 is formed as a generally frusto-conical memberhaving two distinct portions defined by respective differently taperedwalls. Specifically, the valve seal 30 is formed as an elastomericmember having a reinforcing layer 53 formed therewith. This structureprovides the flexibility necessary to expand the valve opening 32 yetprotects the valve seal 30 from damage from a surgical instrument. Anupper seal portion 33 includes an upper inner wall 34 and an upper outerseal wall 35, both formed as a generally unitary portion having a firsttaper. A lower seal portion 38 is integrally formed with the upper sealportion 33 and includes a lower inner seal wall 39 formed unitarily witha lower outer seal wall 40. The lower seal portion 38 includes a taperthat is more sloped and curved than the upper seal portion 33. Thereinforcing layer 53 may be the inner seal wall 39 or the outer sealwall 40. Alternatively, the reinforcing layer 53 may be sandwichedbetween the inner seal wall 39 and the outer seal wall 40.

[0046] Accordingly, the upper seal portion 33 of the valve seal 30tapers from a relatively wide access opening 31 to the lower sealportion 38 where the taper is increased to extend the lower seal portion38 to the instrument seal opening 32. Further, in one embodiment thelower seal portion 38 may be curved slightly inwardly rather than beinga straight conical taper. This construction allows the seal opening 32to move radially, at least a small distance to accommodate an off axisinstrument insertion. Further, the reinforcing layer 53 of the unitaryvalve seal body provides protection against punctures by an instrumentand resists inversion of the valve seal 30 when an instrument iswithdrawn from the valve seal. It should be noted that the valve seal 30may be formed as a single layer without having the reinforcing layer 53formed within. Such a single layer would be formed from a material thatprovides advantages similar to the unitary valve seal body describedabove with respect to puncture resistance, flexibility and sealingcapability.

[0047] With reference now to FIG. 5, an alternate exemplary embodimentof the valve seal shown generally as 130 is shown therein. The mountingportion 141 of valve seal 130 is rigidly mounted in the upper bodyportion 12 at a mounting member 36 on the inner support member 28adjacent the interior portion 37, which opposes the upper surface 16.The mounting portion 141 of valve seal 130, including the mountingmember 36 and the inner support member 28, is rigidly mounted within theupper body portion 12 and incapable of shifting laterally with respectto the upper body portion 12. The valve seal 130 is substantiallysimilar in shape to the valve seal 30 described above except that thelower seal portion 138 is formed with a reinforcing stay 50 described indetail below.

[0048] With reference now to FIG. 6, the position of the reinforcingstay 50 in the valve seal 130 is shown. In an exemplary embodiment, thestay 50 is shaped and sized to approximately match the shape of lowerseal portion 138 of the valve seal 130 and at least a portion of theupper seal portion 133 of the valve seal 130. At least a portion of thereinforcing stay 50 is encapsulated in the lower seal portion 138 of thevalve seal 130 to form a unitary structure.

[0049] As shown in FIGS. 7 and 8, the portion of the reinforcing stay 50that is shaped to match the lower portion 138 of the valve seal 130preferably contains a plurality of flexible reinforcing members 52. Theplurality of flexible members 52 allows the stay 50 to flexproportionally with the elastomeric material of the valve seal when aninstrument is inserted through the valve opening 132. The stay 50 alsosubstantially resists inversion of the valve seal 130 when an instrumentis withdrawn from the valve seal 130. Additionally, in an exemplaryembodiment, the stay 50 has a circumferential flange 54 around theoutside of the stay located above the flexible members 52. As best shownin FIG. 5, the circumferential flange 54 prevents the upper seal portion133 from being pushed into the lower half of inner support member 28.That is, the circumferential flange 54 will come into contact with thelower half of the inner support member 28 upon bending of the upper sealportion 133. Additionally, the stay 50 includes a circumferential upperwall 56 as shown in FIGS. 6 and 7. The upper wall 56 is disposed abovethe circumferential flange 54 and adjacent to the upper seal portion133.

[0050] The valve seals 30 and 130 are preferably made from elastomericmaterials that are able to expand to accommodate a surgical instrumentand form a seal around the instrument. In an exemplary embodiment theelastomeric material is able to resist puncturing from the instrument.Representative elastomeric materials include, but are not limited to,silicone. plastic elastomers, polyisoprene, butyl rubber, neoprene ornatural rubber and the like.

[0051] Representative reinforcing layer materials are those materialssufficient to expand to accommodate a surgical instrument, resistpuncturing from the instrument, form a seal around the instrument andcapable of forming a unitary structure with the elastomeric material.

[0052] The stay 50, as shown in FIG. 5, for example, is made from amaterial that is able to resist inversion when an instrument iswithdrawn from the valve seal. Further, the stay may be made from amaterial that is able to bond with the material of the valve seal 130thereby forming a unitary structure. The bonding may occur by anadhesive or by any other suitable process, by chemical means known toone skilled in the art, or by any other suitable process. Suitablematerials for the stay may include, but are not limited to polyethylene,polypropylene, nylons, plastic elastomers and the like.

[0053] In operation, the seal assembly 10 of the present invention ismounted to a cannula (not shown) using the mating members 26. A surgicalinstrument (not shown) is inserted into the throughbore 20 for passagethrough the instrument seal opening 32 and the duckbill valve 42. If theinstrument is inserted off axis, the valve seal 30 resists puncture andthe lower seal portion 38 allows some movement of the instrument sealopening 32 to accommodate the insertion of the instrument. Further, thecurved taper of the lower seal portion 38 helps to guide the instrumenttoward the instrument seal opening 32. In an exemplary embodiment, thelower seal portion 38 has a curved taper from the bottom of the upperseal portion 33 to the seal opening of 32.

[0054] When the instrument passes through the instrument seal opening 32the elastomeric nature of the valve seal 30 allows the opening 32, toexpand to accommodate the instrument. Typical openings may be 5 mmacross in a relaxed state and may expand up to 12 mm to accommodate theinstrument. It will be appreciated that the seal assembly may beconstructed to accommodate various sizes of instruments. The lower sealwalls 39 and 40 allow the instrument seal opening to fit snugly aroundthe instrument to provide a fluid and gas seal. The instrument is theninserted through the duckbill valve 42. The instrument may then beinserted downwardly into the cannula and, eventually, into the bodycavity.

[0055] When the valve seal 130 is used, the operation is similar to thatdescribed above. A surgical instrument (not shown) is inserted into thethroughbore 20 for passage through the instrument seal opening 132 andthe duckbill valve 42. If the instrument is inserted off axis, theprotector wall 24 helps align the instrument and the valve seal 130resists puncture. The lower body portion 138 allows some movement of theinstrument seal opening 132 to accommodate the insertion of theinstrument. Further, the curved taper of the lower seal portion 138helps to guide the instrument toward the instrument seal opening 132. Inan exemplary embodiment, the lower seal portion 138 has a curved taperfrom the bottom of the upper seal portion 133 to the seal opening of132.

[0056] When the instrument passes through the instrument seal opening132, the elastomeric nature of the valve seal 130 and the flexiblemembers 52 of the stay 50 allows the opening 132 to expand toaccommodate the instrument. As the instrument is inserted through thevalve seal 130, the circumferential flange 54 on the stay 50 engages theinner support member 28 to help prevent the valve seal 130 fromdislodging from the mounting member 36 and acts to prevent the upperseal portion 133 from being pushed into the lower half of inner supportmember 28. Typical openings may be 5 mm across in a relaxed state andmay expand up to 12 mm to accommodate the instrument. It will beappreciated that the scale assembly may be constructed to accommodatevarious sizes of instruments. The lower seal portion 138 allows theinstrument seal opening 132 to fit snugly around the instrument toprovide a fluid and gas seal. The instrument is then inserted throughthe slit 43 in the duckbill valve 42. The instrument may then beinserted downwardly into the cannula and, eventually, into the bodycavity. When the instrument is withdrawn from the valve seal assembly,the flexible members 52 of the stay 50 act to resist inversion of thevalve seal.

[0057] By the above description, the present invention provides asimple, effective surgical instrument seal assembly. The surgicalinstrument seal assembly in accordance with the invention protects thevalve seal from damage from off axis instrument insertions, is costeffective to produce and is durable.

[0058] It will therefore be readily understood by those persons skilledin the art that the present invention is susceptible to broad utilityand application. Many embodiments and adaptations of the presentinvention other than those herein described, as well as many variations,modifications and equivalent arrangement, will be apparent from orreasonably suggested by the present invention and the foregoingdescription thereof, without departing from the substance or scope ofthe present invention.

[0059] Accordingly, while the present invention has been describedherein in detail in relation to its preferred embodiment, it is to beunderstood that this disclosure is only illustrative and exemplary ofthe present invention and is made merely for purposes of providing afull and enabling disclosure of the invention. The foregoing disclosureis not intended or to be construed to limit the present invention orotherwise to exclude any such other embodiments, adaptations variations,modifications and equivalent arrangements the present invention beinglimited only by the claims and the equivalents thereof.

What is claimed is:
 1. A surgical instrument seal assembly for mountingto a cannula for the insertion of a surgical instrument, the sealassembly comprising: an upper body portion having an upper surface thatdefines a throughbore extending completely through the seal assembly; alower body portion projecting below the upper body portion wherein thelower body portion defines a cannula receiving opening adapted to mountthe seal assembly on the cannula; and a unitary valve seal comprising:an upper seal portion having a mounting portion and a generallyfrusto-conical upper sealing member having a first taper extending fromthe mounting portion, wherein the mounting portion is rigidly mounted inthe upper body portion adjacent an interior portion of the upper bodyportion, said interior portion opposing the upper surface, the upperseal portion being mounted about the throughbore, and a lower sealportion extending from the upper seal portion, the lower seal portionbeing adapted to seal around the surgical instrument and having agenerally frusto-conical lower sealing member having a second taper thatis different from the first taper, the frusto-conical lower sealingmember terminating in a distal lower seal end that defines an instrumentseal opening.
 2. A surgical instrument seal assembly according to claim1 wherein the valve seal further comprises a stay wherein at least aportion of the stay is encapsulated in the valve seal.
 3. A surgicalinstrument seal assembly according to claim 2 wherein the stay isunitarily formed with the lower seal portion.
 4. A surgical instrumentseal assembly according to claim 2 wherein the stay is adapted to resistinversion of the valve seal when an instrument is withdrawn from thevalve seal.
 5. A surgical instrument seal assembly according to claim 4wherein the stay is made from a material selected from the groupconsisting of polyethylene, polypropylene, nylon, and plasticelastomers.
 6. A surgical instrument seal assembly according to claim 4wherein the stay has a lower portion encapsulated by the valve sealmaterial and forms a unitary structure.
 7. A surgical instrument sealassembly according to claim 2 wherein the stay is shaped tosubstantially match the lower seal portion.
 8. A surgical instrumentseal assembly according to claim 2 wherein at least a portion of thestay is encapsulated in at least a portion of the lower seal portion. 9.A surgical instrument seal assembly according to claim 8 wherein thestay further comprises a circumferential flange above the at least aportion of the stay encapsulated in at least a portion of the lower sealportion.
 10. A surgical instrument seal assembly according to claim 9wherein the stay further includes a circumferential upper wall disposedabove the circumferential flange.
 11. A surgical instrument sealassembly according to claim 2 wherein at least a portion of the stay isapproximately frusto-conical in shape.
 12. A surgical instrument sealassembly according to claim 2 wherein the stay further comprises aplurality of flexible members.
 13. A surgical instrument seal assemblyaccording to claim 1 wherein the upper seal portion and the lower sealportion are integrally formed from the same material and wherein thevalve seal further comprises a stay that is partially encapsulated inthe lower seal portion.
 14. A surgical instrument seal assemblyaccording to claim 1 wherein the valve seal is formed from anelastomeric material.
 15. A surgical instrument seal assembly accordingto claim 14 wherein the elastomeric material is selected from the groupconsisting of silicone, plastic elastomers, polyisoprene, butyl rubber,neoprene and natural rubber.
 16. A surgical instrument seal assemblyaccording to claim 1, further comprising a duckbill valve in the lowerbody portion.
 17. A surgical instrument seal assembly according to claim1 wherein the lower sealing member has a lower seal wall having an innerwall portion and an outer wall portion, a reinforcing layer beingdisposed intermediate the inner wall portion and the outer wall portion.18. A surgical instrument seal assembly according to claim 17 whereinthe reinforcing layer is integrally formed with at least a portion ofthe inner wall portion.
 19. A surgical instrument seal assemblyaccording to claim 1 wherein the generally frusto-conical lower sealingmember has a lower seal wall terminating at the distal lower seal end,the lower seal wall being curved inward and defining a concave lowersealing member outer surface.
 20. A surgical instrument seal assemblyaccording to claim 1 wherein the throughbore is symmetrically formedaround a bore axis and the upper sealing member defines an accessopening adjacent the mounting portion that has a diameter larger thanthe throughbore, and wherein the valve seal is configured so that uponinsertion of an instrument in an orientation not aligned with the boreaxis, the distal lower seal end and the instrument seal opening willmove radially relative to the bore axis and the instrument accessopening will remain substantially unmoved relative to the bore axis. 21.A valve seal for use in a surgical instrument seal assembly, the valveseal comprising: an upper seal portion having a mounting portion and agenerally frusto-conical upper sealing member having a first taperextending from the mounting portion; and a lower seal portion extendingfrom the upper seal portion, the lower seal portion being adapted toseal around a surgical instrument and having a generally frusto-conicallower sealing member having a second taper that is different from thefirst taper, the frusto-conical lower sealing member terminating in adistal lower seal end that defines an instrument seal opening.
 22. Avalve seal according to claim 21 wherein the lower sealing member has alower seal wall having an inner wall portion and an outer wall portion,a reinforcing layer being disposed intermediate the inner wall portionand the outer wall portion.
 23. A valve seal according to claim 21wherein the upper seal portion and the lower seal portion are integrallyformed from the same material.
 24. A valve seal according to claim 23wherein the upper seal portion and the lower seal portion are formedfrom an elastomeric material.
 25. A valve seal according to claim 24wherein the elastomeric material is selected from the group consistingof silicone, plastic elastomers, polyisoprene, butyl rubber, neopreneand natural rubber.
 26. A valve seal according to claim 21 wherein thevalve seal further comprises a stay wherein at least a portion of thestay is encapsulated in the valve seal.
 27. A valve seal according toclaim 21 wherein the stay is adapted to resist inversion of the valveseal when an instrument is withdrawn from the valve seal.
 28. A valveseal according to claim 21 wherein the stay is made from a materialselected from the group consisting of polyethylene, polypropylene,nylon, and plastic elastomers.
 29. A valve seal according to claim 21wherein the stay is shaped to substantially match the lower sealportion.
 30. A valve seal according to claim 21 wherein the stay furthercomprises a circumferential flange above the at least a portion of thestay encapsulated in the lower seal portion.
 31. A valve seal accordingto claim 30 wherein the stay further includes a circumferential upperwall disposed above the circumferential flange.
 32. A valve sealaccording to claim 31 wherein the stay further comprises a plurality offlexible members.
 33. A valve seal according to claim 21 wherein thestay further comprises a plurality of flexible members.
 34. A valve sealaccording to claim 21 wherein at least a portion of the stay isapproximately frusto-conical in shape.
 35. A valve seal according toclaim 21 wherein the stay has a lower portion encapsulated by the valveseal material and forms a unitary structure.
 36. A valve seal accordingto claim 21 wherein the generally frusto-conical lower sealing memberhas a lower seal wall terminating at the distal lower seal end, thelower seal wall being curved inward and defining a concave lower sealingmember outer surface.
 37. A valve seal according to claim 21 wherein theupper sealing member defines an access opening adjacent the mountingportion, the access opening being symmetrically formed around a boreaxis, and wherein the valve seal is configured so that upon insertion ofan instrument in an orientation not aligned with the bore axis, thedistal lower seal end and the instrument seal opening will move radiallyrelative to the bore axis and the instrument access opening will remainsubstantially unmoved relative to the bore axis.
 38. A valve seal foruse in a surgical instrument seal assembly, the valve seal comprising:an upper seal portion having a mounting portion and a generallyfrusto-conical upper sealing member having a first taper extending fromthe mounting portion, the upper sealing member defining an accessopening adjacent the mounting portion, the access opening beingsymmetrically formed around a bore axis; and a lower seal portionextending from the upper seal portion, the lower seal portion beingadapted to seal around a surgical instrument and having a lower sealwall that curves inward and downward from the upper seal portion andterminates in a distal lower seal end that defines an instrument sealopening, wherein the valve seal is configured so that upon insertion ofan instrument in an orientation not aligned with the bore axis, thedistal lower seal end and the instrument seal opening will move radiallyrelative to the bore axis and the instrument access opening will remainsubstantially unmoved relative to the bore axis.